Kornimate/medical-research-clean huggingface dataset:
study on clostridium difficile infection in infants

Conditions: Clostridium Difficile Infection

Summary: this study aims to investigate the epidemiological characteristics and biomarkers of clostridium difficile infection in infants . by analyzing historical medical data and patient questionnaires, this retrospective cohort study will identify potential high-risk factors and establish baseline biomarkers to improve diagnosis and treatment for affected patients.

this retrospective cohort study focuses on clostridium difficile infection (cdi) in infants n, a relatively rare infection. the study will utilize data from hospital and community to identify the prevalence, risk factors, and unique biomarkers associated with cdi in pediatric patients. key objectives include: (1) analyzing demographic and clinical characteristics of affected patients, (2) evaluating the high-risk factors of cdi, and (3) identifying biomarkers that can aid in early detection and treatment planning. findings from this study are expected to contribute to the improvement of cdi management in pediatric care.

Eligibility criteria:
inclusion criteria: * infants ( aged 0-2 years). medical records and patient questionnaires available with confirmed clostridium difficile infection (for case group) or without infection (for control group). exclusion criteria: * infants beyond the age of 2 years at the time of diagnosis. incomplete medical records or missing essential information related to infection status, feeding methods, or antibiotic exposure.patients with other severe gastrointestinal conditions that may confound results.

Keywords: clostridium difficile infants epidemiology biomarkers
safety and effectiveness of sonu for pediatric nasal congestion

Conditions: Nasal Congestion and Inflammations

Summary: to demonstrate the safety and effectiveness of sonu for the treatment of pediatric patients with moderate to severe nasal congestion.


Eligibility criteria:
inclusion criteria: * pediatric subjects between the ages of 12 to 21 years * present with symptoms of nasal congestion for 1 month or more prior to treatment * have a 24 hour reflective nasal congestion subscore of the tnss of 2 or more on a 0 to 3 scale at the time of screening exclusion criteria: * head, nasal or sinus surgery within 3 months * sinus infection diagnosed within the last month, or rhinitis medicamentosa * documented history of nasal polyposis or mass * pregnancy
a dose escalation and dose expansion study of nox66 in the treatment of covid-19

Conditions: Covid19

Summary: phase ib, open-label, multicenter, study of nox66, given rectally to hospitalized patients with moderate systemic illness due to covid-19 infection at high risk of developing severe sepsis / septic shock.


Eligibility criteria:
key inclusion criteria: 1. hospitalized patient with clinically diagnosis of sars-cov-2 virus infection per world health organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{other confirmatory test results will be accepted upon approval from sponsor/cro medical monitor prior to enrolment}. 2. symptoms suggestive of moderate systemic illness with covid-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress. 3. clinical signs indicative of moderate systemic covid-19 illness (with high risk of developing severe ards/septic shock) with an aggregate of news-2 score of 4-6 or 3 in one single parameter. key exclusion criteria: patients who meet any of the following criteria will be disqualified from entering the study: 1. patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 l/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure. 2. presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>5 x upper limit of normal (uln), platelets \<50,000/µl. 3. treatment with anti-il 6, anti-il-6r antagonists, or with janus kinase inhibitors in the past 30 days or plans to receive during the study period. 4. current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents. 5. use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. 6. history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
safety study of inhaled 552-02 in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. a small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.


Eligibility criteria:
inclusion criteria: 1. male and female patients aged \> 14 years. 2. patients who are diagnosed with cystic fibrosis. 3. patients who have a fev1 ≥ 50% predicted (post-bronchodilator) at screening. 4. patients who are able to perform reproducible spirometry according to ats guidelines. 5. patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening. exclusion criteria: 1. patients who have a fev1 change ≥ 15% after bronchodilator use at screening. 2. patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a fev1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease. 3. patients on angiotensin converting enzyme (ace) inhibitors. 4. patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 meq/l) or serum creatinine \> 2.0 mg/dl. 5. patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, moduretic, midamor; triamterene). 6. patients who are pregnant, have a positive pregnancy test, or are nursing. 7. patients who have had a lung transplant.

Keywords: cystic fibrosis
sensawake™ sleep quality trial

Conditions: Sleep Apnea, Obstructive

Summary: the sensawake™ modification to the fisher and paykel automatically titrating positive airway pressure (apap) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. upon sensing that the patient is awake the device is able to reduce positive airway pressure pap aiming to improve patient comfort which should result in more consolidated sleep. this study will investigate obstructive sleep apnea (osa) and a automatically adjusting positive airway pressure (apap) device with new technology called sensawake™. this requires experimental confirmation in a randomised controlled trial. double-blind randomised crossover trial comparing waso on standard apap with waso using apap modified by the addition of the sensawake™ modification on consecutive nights in participants with moderate-to-severe osa. a total number of 45 participants will be recruited from an osa population, aged 18-65. participants will consist of male and female patients diagnosed with moderate-severe osa (apnea hypopnea index (ahi) greater than or equal to 15 per hour. eligible participants, according to the protocol approved by the hrec, providing written informed consent will be enrolled into the study. patients will be enrolled sequentially according to the randomisation list. patients will be randomised to apap or apap with the addition of the sensawake™ modification. the investigator and study staff will be blinded to the treatment of any participant.


Eligibility criteria:
inclusion criteria: * aged 18-65 years with moderate-to-severe osa (apnea hypopnea index equal to or greater than 15 per hour). * epworth sleepiness scale (ess) scores 0-15 inclusive (normal to moderately severe daytime sleepiness). * fluency in both written and spoken english. * do not have unstable psychiatric disease. * no other significant sleep disorder. exclusion criteria: * participants prescribed and fitted with any pap device in the past 2 years. * unstable cardiovascular disease (untreated or resistant hypertension acceptable). * inability to tolerate cpap due to nasal obstruction or claustrophobia as determined by the study investigator. * any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements. * participation in another clinical trial in the previous month.
the 8 section brocade tai chi therapy for knee osteoarthritis

Conditions: Osteoarthritis, Knee; Tai Chi; Exercise Training

Summary: tai chi exercises have increasingly grown in popularity among older adults in the past decades. it has been well studied to its efficacies in proportion with the management of elderly fall prevention and mineral-structured bone density enhancement. nevertheless, existing study sources do little exemplified a quantifiable measures of effects in patients suffer from osteoarthritis of knees being impacted from a routine performance of tai chi.

112 patients with end stage osteoarthritis knee had enrolled into a customised multidisciplinary education program that consisted of one hour healthcare education seminars followed by another hour of 8 section brocade (baduanjin) sitting tai chi classes for 4 consecutive weeks. followup measures were taken at baseline, 3 and 6 months post course commencement using the international physical activity questionnaire (ipaq), western ontario and mcmaster universities osteoarthritis index (womac), sf-36v2 health survey and the client satisfaction questionnaire (csq-8).

Eligibility criteria:
inclusion criteria: 1. diagnosed in symptomatic knee oa of kellgren lawrence (kl) grade 3 or 4, and have elected on list waiting for lower limb arthroplasty surgery 2. aged 55 or above 3. able to ambulate independently 4. able to communicate in cantonese exclusion criteria: 5. previously underwent total knee replacement surgery 6. diagnosed with other non-oa arthritide forms of the knees 7. unable to complete all four sessions 8. unable to complete all time-point measurements
medication maintenance therapy in community pharmacy settings

Conditions: Opioid-use Disorder

Summary: the goal of this study is to compare pharmacy-based medication assisted treatment (mat) with usual care mat for people with opioid use disorder.

this study compares pharmacy-based medication assisted treatment (mat) with usual care mat. this will be the first study to use a randomized controlled trial design to test the multisite implementation of known effective interventions to treat opioid use disorder and prevent fatal opioid overdose (treatment with buprenorphine and natlrexone) in a community pharmacy setting. understanding how this model can improve engagement in care within innovative systems of mat delivery like the rhode island centers of excellence in mat model as well as the more traditional office based opioid therapy (obot) arrangement, and for patients with shorter and longer time on stabilized mat doses advances the science of addiction health services. this study presents an opportunity to compare clinical outcomes of patients randomized to receive the same medications but in different settings that are equipped with differing levels of counseling expectations and access to wrap-around services. in this way, the trial helps to inform whether-and for whom--the limited support services in the pharmacy are sufficient to engage and retain patients in mat, or if ready access to comprehensive services are necessary. approximately 86% of americans live within 5 miles of a pharmacy, making pharmacists the most accessible health care professionals. this model could redefine the role of the pharmacy. the completed initial phase of the study (phase 1) involved a pilot of the pharmacy mat care model. the current phase of the study (phase 2) is a randomized controlled trial comparing the pharmacy mat care model to usual mat care. the aim of the current phase is to conduct a randomized controlled trial of 250 medication-stabilized (with bnx or ntx) patients with oud receiving mat care in rhode island, comparing engagement and clinical outcomes for patients followed up in a usual care model to those maintained and followed up in a pharmacy mat care model.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english speaking * currently enrolled at a mat site for the treatment of oud, maintained on a stable mat (bnx, ntx) dose for at least 2 days or interested in induction * able and willing to provide written informed consent and secondary contact exclusion criteria: * currently pregnant or trying to get pregnant; * plans to move or leave the state during the study, including pending legal action; * self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan; * patient is currently being treated for an acute illness or has a condition that is not stable including but not limited to an upcoming surgical procedure, hospitalization, or complex treatment regimen (e.g., chemotherapy, hcv treatment, has surgery scheduled, has procedures anticipated, has anticipated dose changes with other medication), that is likely to require ongoing, intense clinical management
treatment of chronic bacterial prostatitis

Conditions: Chronic Bacterial Prostatitis

Summary: background - bacterial prostatitis (bp) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (cbp) classified as type ii, are less common but is a condition that significantly hampers the quality of life, (qol) because not only is it a physical condition but also a psychological distress. commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the european urology guidelines. this approach, although recommended, may not be enough. thus, a multimodal approach to the prolonged antibiotic therapy may be helpful. methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study. all patients were positive to meares-stamey test and symptoms duration was \> 3 months. the purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of serenoa repens 320 mg, lactobacillus sporogens 200 mg, arbutin 100 mg for 30 days). patients were randomized in two groups (a and b) receiving respectively antibiotic alone and an association of antibiotic plus supplement.


Eligibility criteria:
inclusion criteria: * patients affected by chronic bacterial prostatitis * positivity to the meares-stamey test * symptoms duration \> 3 months (dysuria, pelvic pain and/or discomfort) exclusion criteria: * positivity to chlamydia trachomatis, ureaplasma urealiticum, mycoplasma, neisseria gonorrhoeae, herpes simplex viruses (hsv 1/2) and human papillomavirus (hpv) * age less than 18 years * history of neurological disease, urinary stones or cancer * allergy to fluoroquinolones * refusal to sign the informed consent * incomplete follow-up time.
extracorporeal shock wave lithotripsy for treatment of large pediatric renal pelvic stone burden more than 2 cm

Conditions: Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group

Summary: extracorporeal shock wave lithotripsy (swl) was first described for pediatric nephrolithiasis in 1986; swl has been a mainstay of treatment for both renal and ureteral calculi in children . swl is currently regarded as first-line therapy for most renal and upper ureteral calculi \ 2.0 cm . the shock waves are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is higher than adults' kidneys; thus, swl treatment seems likely to be more successful in the pediatric population compared to the adult population .younger age is associated with better stone clearance in children treated with swl, and this is related mostly to increased ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone distance .


Eligibility criteria:
inclusion criteria: * age: 1 year - 5 years old. ( as children younger than 5 years old has shorter skin to stone distance \& the option of endoscopic treatment of stones has is not feasible in this age group) stone size: more than 2 cm \& less than 3.5 cm. stone location: renal pelvis \& other calyces. exclusion criteria: * age: less than 1 year \& more than 5 years old. stone size: less than 2 cm \& more than 3.5 cm. raised serum creatinine , coagulopathy. distal urinary tract obstruction. pulmonary or cardiac disease anatomical abnormalities (upjo, horses shoe kidney, ...)
smart prostate specific antigen (psa) screening study

Conditions: PSA; Prostate Cancer

Summary: this intervention includes the introduction of the prostate cancer working group (pcwg )smart psa screening guidelines and implementation of patient navigation/ care coordination for men with elevated psa (\>4.0 ng/ml). the guidelines include: 1. what age to start? 2. how often to repeat screening? 3. what age to stop? 4. what psa threshold should trigger a biopsy referral?

primary care providers (pcp) hold the key to implementing effective early detection of prostate cancer (pca), but uncertainty about how to use psa for screening without causing undue overtreatment of indolent cancer, has greatly inhibited implementation, even in high-risk communities. this is a single-arm intervention study to test implementation of the smart psa strategy plus system-level patient navigation/ care coordination in the mile square health center(mshc), in order to: a) identify barriers and facilitators to inform implementation of care, b) evaluate the impact on provider confidence regarding prostate cancer screening, and, c) measure its effect on observed psa levels, biopsy referral rates, and biopsy outcomes. 100 pcps employed by mshc who provide care for male adults will be asked to participate in surveys at baseline, (prior to an in-service training) and at 3,6, 9 and 12 months. the surveys will use 5-point likert scales to assess the respondent's self-report of their knowledge regarding psa screening, attitudes, behavior; and confidence in presenting the issue, discussing it with patients, interpreting results and making recommendations based on them; and to elicit comments on how to improve implementation. historical data of 4500 patients covering a one year period prior to the intervention will be used to measure the impact of the intervention on measurable outcomes

Eligibility criteria:
inclusion criteria for pcp: * pcp employed by mshc who provides care for male adult patients exclusion criteria for pcp: * not a pcp employed by mshc who provides care for male adult patients inclusion criteria for patient navigator/care coordinator: * male * age 40-75 * clinic visit at a mshc site * elevated psa (\>4.0 ng/ml) exclusion criteria for patient navigator/care coordinator: • not meeting the inclusion criteria inclusion criteria for chart and database review: * male * age 40-75 * clinic visit at a mshc site from date of study start through 12 months (comparison of 12-month intervention period to periods before and after intervention implementation) exclusion criteria for chart and database review: • not meeting the inclusion criteria
safety and performance assessment of drug-eluting stent cre8 in diabetic patients

Conditions: Diabetes; Coronaropathy

Summary: the study is a 'real-world' study which evaluates the safety and performance of the coronary des-cre8 in diabetic patients. as routine care, each patient will be followed until 12 months after stent implantation.


Eligibility criteria:
inclusion criteria: * ≥18 years old, * patient informed and agreed to participate, * patient with one or more lesions treated with one or more coronary stent cre8, * patient with a diabete insulin dependent or non-insulin dependant. exclusion criteria: * pregnant or breast-feading women, * patient who refused to participate, * patient with another lesion treated during the same intervention with a balloon alone or with another stent
oxidative stress as an acute exercise-induced mechanism of stem and progenitor cell mobilization

Conditions: Healthy

Summary: it is already known from literature that exercise mobilizes stem and progenitor cells into the peripheral blood. however, the exact mechanisms thereof remain to be fully elucidated. the investigators hypothesize that exercise-induced oxidative stress could be at least one of the responsible mechanisms and therefore want to study the exercise-induced stem and progenitor cell mobilization in a group of healthy young men when they exercise with, compared to when they exercise without antioxidative supplementation. the primary outcome is numbers of stem and progenitor cells in the peripheral blood after an acute bout of exercise. as a secondary outcome, numbers of apoptotic mature and immature cells in the blood will be analysed.


Eligibility criteria:
inclusion criteria: * non-smoking * healthy * normal body-mass-index (bmi): 18.5-24.9 kg∙m-2 * active (fulfill world health organization-guidelines for recommended levels of physical activity for adults aged 18 - 64 years) * willing to adhere to the study rules exclusion criteria: * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees and other dependent persons * regular intake of medication * regular intake of antioxidant supplementations
safety and efficacy of sofosbuvir/velpatasvir/voxilaprevir fixed-dose combination with or without ribavirin in participants with chronic genotype 1 hcv infection previously treated with a direct acting antiviral regimen

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (sof/vel/vox) fixed dose combination (fdc) ± ribavirin (rbv) in participants with chronic genotype 1 hepatitis c virus (hcv) infection and prior treatment experience with a direct acting antiviral (daa).


Eligibility criteria:
key inclusion criteria: * individuals with chronic hcv genotype 1 infection * documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response * absence of cirrhosis or presence of compensated cirrhosis * screening laboratory values within defined thresholds * must use specific contraceptive methods if female of childbearing potential or sexually active male key exclusion criteria: * co-infection with hiv or hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * pregnant or a nursing female note: other protocol defined inclusion/exclusion criteria may apply.